Ferritin Rapid Test Reader Diagnostic Test Cassette CE Quantitative detection with LF Reader.

High quality Ferritin Rapid Test Diagnostic Test Cassette CE Mark

Application:

The Ferritin Rapid Test Cassette (Whole Blood/Serum/Plasma) is a quantitative, lateral flow immunoassay for the detection of human ferritin in human serum or plasma and whole blood. The membrane is precoated with anti-ferritin polyclonal antibody on the test line region. And the membrane is precoated with Goat anti Rabbit IgG on the reference line region.

The gold is precoated with anti-ferritin monoclonal antibody and Rabbit IgG. During testing, the specimen reacts with the particle coated with anti-ferritin monoclonal antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-ferritin polyclonal antibody on the membrane and generate a colored line.

The line in test line region (T) appears, if the ferritin level exceeds the cut-off level of 13ng/ml. If the ferritin concentration is less than 13ng/ml, the test line not appears. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.

For serum or plasma specimen:

1. Bring the pouch to room temperature (15-30℃) before opening it. Remove the cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 1 full drop of serum or plasma (approximately 25μL) to the specimen well of the cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.

3. Wait for the colored line(s) to appear. The result should be read with LF Reader at 5 minutes.

4. Do not interpret test results visually.

5. For LF Reader installation, start up and complete instructions refer to AllTest^TM LF Reader User Manual. Operator must consult LF Reader User Manual prior to use and become familiar with the processes and quality control procedures.

For whole blood specimen:

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.

2. Place the cassette on a clean and level surface.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen well, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. The result should be read with LF Reader at 5 minutes.

4. Do not interpret test results visually.

5. For LF Reader installation, start up and complete instructions refer to LF Reader User Manual. Operator must consult LF Reader User Manual prior to use and become familiar with the processes and quality control procedures

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.